Breast cancer is one of the health threats most feared by women, and is the most common form of cancer in women. A key to treatment is early detection. For example, an annual mammogram is a method that has been used in hopes of early detection of breast cancer. One problem with mammography is that such an imaging technique can only find breast cancer once it has taken form. All too often, breast cancer is discovered at a stage that is too far advanced, when therapeutic options and survival rates are severely limited. As such, more sensitive and reliable methods and devices are needed to detect cancerous, pre-cancerous, and other cancer markers of the breast at an early stage. Such methods and devices could significantly improve breast cancer survival. While breast cancer is most common among women, in rare instances the human male may also have occurrences of breast cancer.
Other methods of detecting breast cancer are based on the fact that a vast majority of instances of breast cancer begins in the lining of mammary ducts. Studies have shown that fluid within the mammary duct contains high levels of breast cancer markers, and that an estimated 80%-90% of all breast cancers occur within the intraductal epithelium of the mammary glands. Fluid within the breast ducts contains an assemblage and concentration of hormones, growth factors and other potential markers comparable to those secreted by, or acting upon, the surrounding cells of the alveolar-ductal system. Likewise, mammary fluid typically contains cells and cellular debris, or products that can also be used in cytological or immunological assays. Procedures for obtaining such samples include ductal lavage, expression or aspiration of mammary duct fluid, and collection of mammary duct discharge.
It is sometimes desirable to increase the yield of cells and cellular debris through use of an intraductal brush to loosen and dislodge cellular material from the intraductal epithelium of the mammary glands. An endoscope may be used to guide the brush to the desired region of a mammary duct. The brushing device usually has soft bristles set in twisted strands of wire. Using the wire to pull the bush in opposite directions, the bristles are brushed over the inner wall of the duct at the stricture in an effort to displace cells from the duct wall and capture the cells in the bristles. The soft nature of the bristles and the absence of adequate radial force directing the bristles into the epithelium reduce the likelihood of an adequate yield.
Such brush biopsy devices also offer no papilloma or carcinoma biopsy capability because they cannot effectively excise a tissue sample from the area of stricture. If a particular papilloma or carcinoma is discovered, such as by an endoscopic viewing, a separate procedure needs to be performed to excise and collect a biopsy of the papilloma or carcinoma. For example, a biopsy of the area of the stricture is typically obtained by passing a different instrument, such as biopsy forceps, to the papilloma or carcinoma, and then cutting away and removing the tissue sample. Another method for taking a biopsy of a region in a mammary duct is through the use of a slotted cannula. A distal end of a cannula includes a single opening through which a papilloma or carcinoma may pass. The cannula is rotated or twisted after the papilloma or carcinoma is passed through the window, and thereby the papilloma or carcinoma is excised. A need exists for a device that is capable of performing both a brushing biopsy and an excision without requiring multiple instruments.